A placebo-controlled dose-ranging study of lansoprazole in the management of reflux esophagitis.
OBJECTIVE
We compared the efficacy of three different doses of the proton pump inhibitor lansoprazole in the management of reflux esophagitis.


METHODS
Two hundred ninety-two patients with endoscopically confirmed reflux esophagitis were enrolled in a double-blind, multicenter study and were randomized to lansoprazole 15, 30, or 60 mg or placebo administered once daily for 8 wk.


RESULTS
Healing rates after 4 wk of lansoprazole 15, 30, and 60 mg/d were 67.6%, 81.3%, and 80.6%, respectively. These were all significantly superior (p < 0.001) to placebo, which produced endoscopic healing in only 32.8% of the patients after 4 wk. The 4-wk healing rates with lansoprazole 30 or 60 mg were significantly higher than that with lansoprazole 15 mg (p < 0.05), confirming a dose-response effect. Cumulative healing rates after 8 wk of treatment were 52.5% with placebo and 90.0%, 95.4%, and 94.4% with lansoprazole 15, 30, and 60 mg, respectively (p < 0.001 for all doses of lansoprazole vs placebo). Lansoprazole was also significantly superior to placebo in relieving symptoms in patients with reflux esophagitis. Lansoprazole was well tolerated, and no serious treatment-related adverse events were encountered. Up to 3 months after discontinuation of treatment, all lansoprazole-treated groups had more patients free of endoscopic evidence of esophagitis than the group treated with placebo.


CONCLUSIONS
Lansoprazole was safe and effective for the treatment of reflux esophagitis in this trial. This study indicates that the optimum daily dose of lansoprazole for reflux esophagitis is 30 mg.
Earnest
D L
DL
University of Arizona Health Sciences Center, Tucson, USA.
Dorsch
E
E
Jones
J
J
Jennings
D E
DE
Greski-Rose
P A
PA
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D054328:Proton Pump Inhibitors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole